Comparing two surgical techniques for treating cervical cancer

A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer

This study is testing whether a new type of minimally invasive surgery for cervical cancer works better and has fewer complications than the traditional surgery for patients with early-stage disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 524 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Lanzhou, Gansu and 16 other locations)
• Trial ID: NCT06836869 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) compared to traditional abdominal radical hysterectomy (ARH) for patients with FIGO stage IB2 cervical cancer. Participants will be randomly assigned to undergo either LRH-MTF or ARH and will be monitored for disease-free survival rates and complications over a period of 4.5 years post-operation. The study also includes follow-up assessments and quality-of-life questionnaires to gather comprehensive data on patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 18 to 65 with histologically confirmed FIGO stage IB2 cervical cancer.

Not a fit: Patients with special pathological types of cervical cancer or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive surgical option for patients with cervical cancer, potentially leading to improved recovery and quality of life.

How similar studies have performed: Other studies have shown promising results with laparoscopic techniques in various cancers, suggesting potential success for this approach, although this specific comparison is novel.

Eligibility criteria

1. Inclusion Criteria:

   1.1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

   1.3 FIGO 2018 stage IB2. 1.4 The maximum diameter of the cervical lesion measured by MRI is \>2 cm and ≤4 cm. For those with MRI contraindications, PET/CT, CT, or ultrasound can be used as alternatives.

   1.5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

   1.7 Willing to participate in this trial and sign the informed consent form. 1.8 Able to cooperate and complete follow - up and relevant examinations. 1.9 For pre - menopausal women, a negative pregnancy test within 30 days before surgery.

   1.10 Laboratory test indicators of vital organs meet the standards
2. Exclusion Criteria:

2.1 Special pathological types (gastric - type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma, etc.).

2.2 Imaging examinations suggest pelvic or para - aortic lymph node metastasis (MRI or CT shows a short - axis diameter of ≥1.5 cm, or SUV ≥2.5), or histopathology indicates lymph node metastasis.

2.3 History of pelvic and abdominal radiotherapy. 2.4 History of neoadjuvant chemotherapy. 2.5 Uterus larger than that at 10 weeks of pregnancy. 2.6 Contraindications for surgery and anesthesia (such as severe medical comorbidities).

2.7 Patients who cannot tolerate the Trendelenburg position. 2.8 Patients who cannot cooperate with treatment and follow - up. 2.9 Pregnant patients. 2.10 History of other malignancies, except for those who have been cancer - free for more than 3 years with no current evidence of tumor recurrence.

Where this trial is running

Lanzhou, Gansu and 16 other locations

• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (NOT_YET_RECRUITING)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (RECRUITING)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (RECRUITING)
• Hunan Provincial Maternal and Child Health Care Hospital — Changsha, Hunan, China (RECRUITING)
• The Second Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
• Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School — Shanghai, Shanghai Municipality, China (RECRUITING)
• Affiliated Hospital of Shanxi University of Traditional Chinese Medicine — Xianyang, Shanxi, China (RECRUITING)
• The Fourth Military Medical University, Xijing Hospital — Xi’an, Shanxi, China (RECRUITING)
• Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (RECRUITING)
• Zhejiang cancer hospital — Hangzhou, Zhejiang, China (RECRUITING)
• Peking Union Medical College Hospital — Beijing, China (RECRUITING)
• Sichuan Cancer Hospital and Institute — Chengdu, China (RECRUITING)
• Southwest Hospital — Chongqing, China (RECRUITING)
• Obstetrics & Gynecology Hospital of Fudan University — Shanghai, China (RECRUITING)
• Tianjin Central Hospital of Gynecology Obstetrics — Tianjin, China (RECRUITING)
• Tongji Medical College — Wuhan, China (RECRUITING)

Study contacts

• Study coordinator: Yuan Li, professor

Conditions: Cervical Cancer Stage IB2, radical hysterectomy, Modified Tumor-Free Techniques, cervical cancer, FIGO stage 1B2, laparotomy, laparoscopic surgery